Cleared Traditional

K161871 - EVA (Enhanced Visual Assessment) System

K161871 is an FDA 510(k) clearance for EVA (Enhanced Visual Assessment) System, manufactured by Mobileodt , Ltd.. The device is a Class 2 Obstetrics & Gynecology device with product code HEX cleared through the Traditional 510(k) pathway after a 165-day FDA review.

K161871 · Mobileodt , Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2016
Decision
165d
Days
Class 2
Risk

K161871 is an FDA 510(k) clearance for the EVA (Enhanced Visual Assessment) System. Classified as Colposcope (and Colpomicroscope) (product code HEX), Class II - Special Controls.

Submitted by Mobileodt , Ltd. (Tel Aviv, IL). The FDA issued a Cleared decision on December 19, 2016 after a review of 165 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1630 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K161871

510(k) Number K161871 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 2016
Decision Date December 19, 2016
Days to Decision 165 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 161d · This submission: 165d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HEX Device Classification - Class 2, Special Controls

Product Code HEX Colposcope (and Colpomicroscope)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1630
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - HEX Colposcope (and Colpomicroscope)

All 46
Devices cleared under the same product code (HEX) and FDA review panel - the closest regulatory comparables to K161871.
Biop Digital Colposcope
K182764 · Biop Medical , Ltd. · Nov 2018
Pocket Colposcope System
K181034 · Hadleigh Health Technologies, LLC · Sep 2018
LT-300 SD Digital Video Colposcope
K170446 · Lutech Industries, Inc. · May 2017
Colposcope System
K160341 · Xuzhou Kernel Medical Equipment Co., Ltd. · Sep 2016
LT-300 HD
K160380 · Lutech Industries, Inc. · May 2016
Video Colposcope
K151878 · Edan Instruments, Inc. · Dec 2015